510(k) K913618
- Device
- ARBOVIRUS IGM IFA TEST
- Applicant
- HILLCREST BIOLOGICALS
- 510(k) number
- K913618
- Product code
- GQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-03
- Date received
- 1991-08-13
- Regulation
- 866.3240
- Classification name
- Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROLYN WAGNER
- Address
- 10703 Progress Way Cypress CA US 90630 90630
FDA Registration Numbers#
- 2023365
- 2242436
- 9681540
Source Documents#
Other 510(k) Records For Product Code GQC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K913617 | ARBOVIRUS IGG IFA TEST | Hillcrest Biologicals | 1992-12-03 |
Legacy Summary#
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FDA Review#
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